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OpenTrials
Completed

NCT Number: NCT02860195

Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration

A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration.

One of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods.

The purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.

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Key information

Conditions

The Sweat Alcohol Concentration

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 18-40 years, age-matched (+ 3 years)
  • Caucasian
  • BMI: 19 to 28 kg/m2
  • No smoking or light smoker (<5 cig/d)
  • Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience

Exclusion criteria

  • Subjects with addiction to toxic or alcohol (MINI Questionnaire)
  • Positive individuals in search of drugs and toxic
  • Anxiety or depressive subjects (IASTA Questionnaires and BDI)

Treatment and study plan

oral dose of alcohol

Other

alcotest

Device

blood samples

Biological

Transdermal monitor

Device

Primary outcomes

  1. The determination of ethanol in the plasma

    Time frame: 6 months

    blood samples

Secondary outcomes

  1. measures in the exhaled air

    Time frame: 6 months

    Assessed with the device Alcotest®

  2. sweat alcohol concentration

    Time frame: 6 months

    assessed with a Transdermal monitor

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: ALCOOCAPT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.